Description and Brand Names

US Brand Name

Dostinex

Descriptions

Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas (tumors of the pituitary gland).

It works by stopping the brain from making and releasing the prolactin hormone from the pituitary gland. Cabergoline use is usually stopped when prolactin levels are normal for 6 months. It may be given again if symptoms of too much prolactin occur again.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cabergoline in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cabergoline in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving cabergoline.

Pregnancy

Information about this cabergoline-oral-route

Pregnancy Category

Explanation

All Trimesters

B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Fibrotic disorders (scar-like tissues in the heart, lungs, or stomach), history of or

Heart problems (e.g., heart valve disease), history of or

Hypertension (high blood pressure), uncontrolled—Should not be used in patients with these conditions.

Heart disease or

Lung disease or other breathing problems—Use with caution. May make these conditions worse.

High blood pressure, controlled or

High blood pressure of pregnancy, or history of—Cabergoline usually decreases blood pressure but at times it may increase blood pressure and worsen these conditions.

Liver disease—Use with caution. You may need a lower dose of this medicine.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For disorders of high prolactin levels or pituitary tumors:

Adults—At first, 0.25 milligram (mg) two times a week. Your doctor may increase your dose every 4 weeks as needed, according to body prolactin levels, up to 1 mg two times a week.

Children—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

However, if it is almost time for your next dose, check with your doctor to see if you can double your dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits while you are taking this medicine to make sure that this medicine is working properly. Blood and other tests for the heart may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant or planning to become pregnant. Tell your doctor right away if you think you might be pregnant at any time while you are using this medicine. If you are pregnant, make sure your doctor knows if you also have high blood pressure. You and your doctor should discuss whether you should continue to take this medicine during pregnancy.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help.

Check with your doctor right away if you have symptoms of fainting, hallucinations (seeing, hearing, or feeling things that are not there), lightheadedness, stuffy nose, or racing heartbeat.

This medicine may increase your risk of having serious heart, kidney, lung, or stomach problems. Check with your doctor right away if you have chest pain or tightness; extreme tiredness; lower back or side pain; lump or tenderness in the stomach; persistent cough; shortness of breath; troubled breathing; or swelling in your hands, ankles, lower legs, or feet.

Also tell your doctor if you have persistent cough along with shortness of breath or troubled breathing while you are using this medicine. This could be symptoms of a serious lung disorder called pulmonary fibrosis.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

fast, irregular, pounding, or racing heartbeat or pulse

general feeling of discomfort or illness

rapid weight gain

swelling around the eyes

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Chest pain or tightness

continuing loss of appetite

continuing or severe abdominal or stomach pain

continuing or severe nausea and vomiting

cough

decreased ability to exercise

fever

increased frequency of urination

loss of appetite

lower abdominal or stomach pain

lower back pain

nausea

shortness of breath

trouble with breathing

vomiting

weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Fainting

seeing, hearing, or feeling things that are not there

stuffy nose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement (stool)

dizziness

excess air or gas in the stomach or intestines

full feeling

headache

lack or loss of strength

passing gas

Less common

Abdominal or stomach pain

acid or sour stomach

anxiety

belching

blemishes on the skin

breast pain

burning, itching, or stinging of the skin

changes in vision

cramps

depression

diarrhea

difficulty with moving

dry mouth or toothache

feeling of constant movement of self or surroundings

feeling of warmth

gas

heartburn

heavy bleeding

indigestion

itching skin

joint pain

muscle aches and pains

muscle stiffness

pimples

redness of the face, neck, arms, and occasionally, upper chest

runny nose

sensation of spinning

shivering

sleeplessness

sleepiness or unusual drowsiness

sneezing

sore throat

stomach discomfort or upset

sudden sweating

trouble with sleeping

unable to sleep

weight loss

Rare

Bloody nose

difficulty in concentrating

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

Incidence not known

Attack, assault, or force

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

hair loss or thinning of the hair

pathological gambling

severe mood or mental changes

unusual behavior

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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